FDA Publishes Two New Draft Guidances for Industry

Today, October 3, 2017, the FDA published two new draft guidances for industry:    

• ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFAThis draft guidance explains how the review goals established as part of the Generic Drug User Fee Amendments (GDUFA II) apply to amendments to Abbreviated New Drug Applications (ANDAs) or prior approval supplements (PASs) submitted to the FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)). It also describes amendment classifications and categories and explains how amendment submissions may affect an application’s review goal dates. Finally, the draft guidance describes how the FDA should review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the GDUFA II review goals’ effective date. When finalized, this guidance will replace the December 2001 guidance for industry, Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications. It also supersedes the July 2014 draft guidance for industry, ANDA Submissions – Amendments and Easily Correctable Deficiencies under GDUFA.To comment on the draft guidance, please visit the public docket, FDA-2017-D-5670.Additionally, the FDA has recorded a webinar to walk applicants through this guidance. The presentation and accompanying slides are available on FDA.gov.
  

• Refuse-to-Receive Standards: Questions and AnswersThis draft guidance is intended to assist applicants preparing to submit abbreviated new drug applications (ANDAs) and certain prior approval supplements to ANDAs. This guidance provides answers to questions the Agency has received from applicants regarding the guidance for industry “ANDA Submissions—Refuse-to-Receive Standards” and the ANDA filing process in general. The subject areas covered by this guidance include: the organization of an ANDA, filing decisions made by FDA, the review of and deficiencies related to Drug Master Files, product quality, bioequivalence, and clinical review. The chosen subjects are intended to clarify the deficiencies that may cause FDA to refuse to receive (RTR) an ANDA. An RTR decision indicates that FDA has determined that an ANDA is not a substantially complete application (i.e., that the ANDA, as submitted, is not sufficiently complete to permit a substantive review). The FDA plans to update this draft guidance to include additional questions and answers as appropriate.To comment on the draft guidance, please visit the public docket, FDA-2017-D-5846.